Directional programming for implantable electrode arrays

• US 6,393,325 B1
• Filed: 04/17/2000
• Issued: 05/21/2002
• Est. Priority Date: 01/07/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Meadows, Paul M., Peterson, David K. L., Mann, Carla M.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US09/550,217
• Time in Patent Office: 764 Days
• Field of Search: 607/46, 607/59, 607/66, 607/148
• US Class Current: 607/46
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

A programming system and method for use with an implantable tissue stimulator allows a clinician or patient to quickly determine a desired electrode stimulation pattern, including which electrodes of a multiplicity of electrodes in an electrode array should receive a stimulation current, including the amplitude, width and pulse repetition rate of such current. Movement of the selected group of electrodes is facilitated through the use of a directional pointing device, such as a joystick. As movement of the selected group of electrodes occurs, current redistribution amongst the various electrode contacts takes place. The redistribution of stimulus amplitudes utilizes re-normalization of amplitudes so that the perceptual level remains fairly constant. This prevents the resulting paresthesia from falling below the perceptual threshold or above the comfort threshold. A software wizard provides a software interface, including the use of easy-to-understand instructional, data-gathering and/or parameter-setting screens, that walks a user step by step through the programming process.

Claims

1. A programming system for use with a neural stimulation system comprising:

a multiplicity of implantable electrodes adapted to contact body tissue to be stimulated;

an implantable pulse generator connected to each of the multiplicity of electrodes, the implantable pulse generator comprising a battery and electrical circuitry, wherein the battery provides operating power for the electrical circuitry, and wherein the electrical circuitry includes means for receiving progranmming signals and means responsive to the programming signals for selectively activating a plurality of the implantable electrodes, wherein at least one electrode in the plurality of activated implantable electrodes is coupled to the battery through the electrical circuitry so as to function as a cathode, and wherein at least one electrode in the plurality of activated implantable electrodes is coupled to the battery through the electrical circuitry so as to function as an anode, whereby stimulus current flows from the at least one activated anodic electrode to the at least one activated cathodic electrode;

a programming device adapted to be coupled with the implantable pulse generator, the programming device having control logic means therein for generating the programming signals sent to the implantable pulse generator; and

a user-controlled input device coupled with the progranmming device, wherein the user-controlled input device includes means for generating directional signals as a function of user control; and

wherein the control logic means within the programming device includes means for generating programming signals for continuously activating selected ones of the multiplicity of implantable electrodes and continuously shifting stimulus current without interruption among cathodic and anodic electrodes in response to the directional signals received from the user-controlled input device.

2. The programming system of claim 1 wherein the means for selectively activating a plurality of electrodes within the electrical circuitry of the implantable pulse generator includes current source means for forcing a prescribed current to flow from an anodic electrode.

3. The programming system of claim 1 wherein the means for selectively activating a plurality of electrodes within the electrical circuitry of the implantable pulse generator includes current sink means for forcing a prescribed current to flow into a cathodic electrode.

4. The programming system of claim 1 wherein the means for selectively activating a plurality of electrodes within the electrical circuitry of the implantable pulse generator includes means for causing a prescribed positive voltage to be applied to an anodic electrode.

5. The programming system of claim 1 wherein the means for selectively activating a plurality of electrodes within the electrical circuitry of the implantable pulse generator includes means for causing a prescribed negative voltage to be applied to a cathodic electrode.

6. The programming system of claim 1 wherein the control logic means includes table-based algorithm means for redistributing current from one of the multiplicity of implantable electrodes to another.

7. The programming system of claim 6 wherein the table-based algorithm means includes means for redistributing current from one implantable electrode to another in small step sizes while maintaining intensity perception relatively constant.

8. The programming system of claim 1 wherein the control logic means includes a formula-based algorithm means for redistributing current from one of the multiplicity of implantable electrodes to another.

9. The programming system of claim 8 wherein the formula-based algorithm means includes means for redistributing current or voltage amplitudes X={x₁, x₂, . . . , x_n} on n electrodes to a second distribution of current or voltage amplitudes Y={y₁, y₂, . . . y_n} in a way that satisfies the following relationship:

$\underset{i=1}{\overset{n}{\sum <br><br>}}<br><br>{\left(x_i-y_i\right)}^2<<br><br>\mathrm{Maximum}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{of}<br><br>\text{\hspace{1em}<br><br>}\left[\underset{i=1}{\overset{n}{\sum <br><br>}}<br><br>{\left(x_i-y_i\right)}^2\right].$

10. The programming system of claim 1 wherein the programming device includes a display screen, and wherein the control logic means includes means for displaying a graphical representation of changes in the stimulus current on the display screen.

11. The programming system of claim 10 further including a fitting process for fitting the neural stimulation system to a user that includes means for setting current stimulus levels and selected anodic and cathodic electrodes to values and groupings of electrodes that are most efficacious for the user, and wherein the control logic means further includes means for defining stimulus levels in terms of normalized values that range between a minimum perception level and a maximum comfortable level.

12. The programming system of claim 11 wherein the control logic means further includes means for presenting a sequence of instructional displays on the display screen that walks a user through each step of the fitting process.

13. The programming system of claim 12 wherein the control logic means further includes means for presenting a map on the display screen that depicts the various steps along a path that leads to a successful fitting of the neural stimulation system to the user.

14. The programming system of claim 13 wherein the control logic means also includes means for visually marking on the display screen the location of the user along the path leading to a successful fitting of the neural stimulation system.

15. A method of stimulating a user with a neural stimulation system comprising:

positioning a multiplicity of electrodes so as to contact body tissue of the user;

selectively activating a plurality of the electrodes and applying a stimulus current through the activated plurality of electrodes to stimulate body tissue in contact with the activated electrodes;

generating directional signals as a function of where the user wants to move the stimulus current;

continuously shifting, without interruption, the stimulus currents from a first set of activated plurality of electrodes to a second set of activated plurality of electrodes in response to the directional signals so that the stimulus current applied through the first set of electrodes is gradually reduced in amplitude proportionately to a gradual increase in amplitude of the stimulus current applied through the second set of electrodes.

16. The method of claim 15 further including maintaining a relative perceived intensity of the applied stimulus currents that is substantially constant as the stimulus currents are shifted from one activated electrode set to another.

17. An electrode selection/programming-system comprising:

a neural stimulation system, the neural stimulation system having a multiplicity of implantable electrodes;

an implantable pulse generator connected to the implantable electrodes;

electrical circuitry means within the implantable pulse generator for applying a prescribed current stimulus through a selected configuration of the implantable electrodes;

an external programming device coupled to the implantable pulse generator;

means within the external programming device for allowing a clinician to readily select the prescribed current stimulus and select a particular group of electrodes of the multiplicity of implantable electrodes through which the prescribed current stimulus is to be applied;

means within the external programming device for programming the prescribed current stimulus to take on different combinations of pulse amplitude, pulse width, and pulse repetition rates;

an input device having means for generating directional signals as a function of manual manipulation; and

current shifting means within the external programming device responsive to the directional signals for moving the prescribed current stimulus from one group of electrodes to another in a continuous current shifting process.

18. The electrode selection/programming system of claim 17 wherein the external programming device further includes means for interpreting the directional signals generated by the input device based on at least one of:

a table-based algorithm, a mathematical formula, and a mathematical model.

19. The electrode selection/programming system of claim 18 further including means within the external programming device for generating and displaying a sequence of instructional displays that guide a user through the process of selecting a group of electrodes and programming the neural stimulation system so as to assist a user of the neural stimulation system to use only those electrodes that prove most effective for a desired purpose, and so that the selected electrodes receive a pulsed current having an amplitude, width and repetition frequency that best meets the needs of the user.